BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*

    K Number: K910586 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    18
    Applicant Total
    218
    Review Days
    24

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    Basic Information

    Device Name
    AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
    K Number
    K910586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4760
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    February 11, 1991
    Decision Date
    March 7, 1991
    Product Code
    GDT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GDT Staple, Removable (Skin)

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